Occlusion effect mitigation and sound isolation device for orifice inserted systems

ABSTRACT

Methods and devices for sound isolation are provided. A sound isolation device includes an expandable element and an insertion element. The expandable element is operatively attached to the insertion element. The expandable element includes an expanding medium, where the pressure of the expanding medium is varied to vary a sound isolation across the expandable element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/492,164, filed Jun. 26, 2009 which claims the benefit of U.S.provisional patent application No. 61/076,122 filed on 26 Jun. 2008. Thedisclosure of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to devices that can be inserted intoorifices and sealed, and more particularly although not exclusivelyrelated to earpieces with expandable systems.

BACKGROUND OF THE INVENTION

The occlusion effect is generally described as the sensation ofincreased loudness (sound pressure level), especially in the lowfrequencies, that a person experiences to self-generated sounds(vocalization, chewing, swallowing, walking, and the like), when theears are covered (occluded). Note that this resonance amplification canoccur in tubes that have a sealed volume and have acoustic leakage intothe volume. The occlusion effect has been identified as a major obstacleto successful hearing aid use and shallow (within the first ½ of thechannel) inserted earpieces. The theories of why the occlusion effectforms and what it is are numerous and diverse and to date no singleexplanation has been totally accepted.

FIG. 3 illustrates typical occlusion effect levels as a function offrequency for various in-ear devices.

There are several theories of the occlusion effect. They include outflowtheory (Mach, 1863): occlusion of the ear canal results in an increasein middle ear impedance, and hence to a decrease in energy lost from theinner ear via the ossiculaer chain. Resonance theory (Huizing, 1923):increased perception of sound is brought about by the walls of thisartificially closed cavity acting as resonators. Masking theory(Pohlman, 1930; Hallpike, 1930): occlusion of the ear canal eliminatesmasking influence of ambient noise. Inertial/osseotympanic theory (vonBekesy, 1932): the occlusion effect results from sound pressure increasein the auditory canal with occlusion. Inertia of the mandible to theskull sets up pressure variations in EAM. Impedance theory (Huizing,1960): occlusion alters the impedance of the column of air in the canal(increasing it), resulting in improved coupling of the air in the canalto the middle ear.

FIG. 4 illustrates several occlusion effect studies and their values atvarious frequencies for earphones, while FIG. 5 illustrates severalocclusion effect studies for earmolds. Roughly the occlusion effect isin the range of 13-25 dB between 250-500 Hz. Roughly from Killion,Wilber, and Gudmundsen (1988) a shallow insertion has an occlusioneffect of about 13 to 21 dB, while a deep insertion has an occlusioneffect of about 20 dB for a tapered tip, and about −9 to 4 dB for a bonycontact ear inserted device. Related art solutions involve acousticvents between the sealed region (now unsealed) and the outsideenvironment of about 3 mm in diameter, however venting has limitationsas well, for example ringing. Another solution is deep insertion withcontact in the bony section of the ear canal.

Thus for shallowly inserted systems (e.g., <½ the ear canal length), theocclusion effect can be an issue (e.g., >5 dB).

SUMMARY OF THE INVENTION

At least one exemplary embodiment is directed to an occlusion effectmitigation device comprising: an insertion element; and an expandableelement operatively attached to the insertion element, where theexpandable element is configured to expand against a portion of thewalls of a flexible channel forming a sealed chamber in the channel,where the expansion reduces the occlusion effect in the sealed chamber.

At least one exemplary embodiment is directed to a sound isolationdevice comprising: an expandable element; and an insertion element,where the expandable element is operatively attached to the insertionelement, where the expandable element includes an expanding medium,where the pressure of the expanding medium is varied to vary soundisolation across the expandable element.

At least one exemplary embodiment is directed to a method of soundisolation comprising: expanding an element to a first pressure where theexpanded element varies the sound isolation across the element as thepressure exerted by the expanding element is varied.

At least one exemplary embodiment is directed to a method of occlusioneffect reduction comprising: inserting an insertion element into aflexible channel; and expanding an expanding element, where uponinsertion of the insertion element and expansion of the expandingelement a sealed chamber is formed, where when the expanding elementpresses against a portion of a wall of the flexible channel, theocclusion effect in the sealed chamber is reduced.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the present invention will become more fullyunderstood from the detailed description and the accompanying drawings,wherein:

FIG. 1 illustrates an ear canal as a non-limiting example of an orificethat can be sealed forming a resonance chamber;

FIG. 2 illustrates occlusion effect values of at least one exemplaryembodiment when the device is sealed at various sound isolation values;

FIGS. 3-5 illustrates various values of the occlusion effect accordingto several scientific studies;

FIG. 6 illustrates sound isolation values (e.g., acoustic energyabsorption and reflection) for an inflatable system according to atleast one exemplary embodiment;

FIG. 7 illustrates an inflatable device in accordance with at least oneexemplary embodiment;

FIGS. 8-13, and 15 illustrate at least one method of inflating aninflatable device in accordance with at least one exemplary embodiment;and

FIGS. 14A, 14B, and 14C illustrate various non-limiting examples ofelectrode configurations in accordance with at least one exemplaryembodiment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE PRESENT INVENTION

The following description of exemplary embodiment(s) is merelyillustrative in nature and is in no way intended to limit the invention,its application, or uses.

At least several exemplary embodiments are directed to or can beoperatively used on various wired or wireless earpiece devices (e.g.,earbuds, headphones, ear terminal, hearing aids, behind the ear devices,or other acoustic devices as known by one of ordinary skill in the art,and equivalents).

Processes, techniques, apparatus, and materials as known by one ofordinary skill in the art may not be discussed in detail but areintended to be part of the enabling description where appropriate. Forexample material fabrication may not be disclosed, nor attachmentprocedures (e.g., adhesive attaching of separate ridge structures), butsuch, as known by one of ordinary skill in such arts is intended to beincluded in the discussion herein when necessary.

Notice that similar reference numerals and letters refer to similaritems in the following figures, and thus once an item is defined in onefigure, it may not be discussed or further defined in the followingfigures.

FIG. 1 illustrates a sealed (occluded) ear canal 50, with a sealedvolume 30. Voice can leak 80 into the sealed volume 30 from varioussource paths 80A, 80B, and 80C. Source paths 80A and 80B represent soundconducted from bones 10 adjacent to ear canal 50. Source path 80Crepresents sounds 90, 95 to ear canal 50 from areas of the inner ear. Inone explanation, the leaked acoustic energy results in an amplification(e.g., by resonance) at certain frequencies within the sealed volume,resulting in the occlusion effect. If the ear canal (a non-limitingexample of an orifice) was unsealed then no resonance could build andhence there would be no occlusion effect. While the present inventionhas been described with reference to exemplary embodiments, it is to beunderstood that the invention is not limited to the disclosed exemplaryembodiments. The scope of the following claims is to be accorded thebroadest interpretation so as to encompass all modifications, equivalentstructures and functions of the relevant exemplary embodiments. Forexample exemplary embodiments do not require the formation of a sealedchamber in the channel, exemplary embodiments can increase the soundisolation across the sealed section of the channel.

FIG. 1 illustrates at least one exemplary embodiment. An earpiece 100can include an insertion element 75 operatively connected to a sealingsection. The sealing section can include an expandable element 70 (e.g.,expanding polymers, inflatable systems, mechanically expanded systems,balloons of various shapes, sizes and materials, for example constantvolume balloons (low elasticity <=50% elongation under pressure orstress) and variable volume (high elastic >50% elongation under pressureor stress) balloons). Many materials can be used for the expandableelement 70. For example if the interior medium is air then the material(e.g., membrane) for the expandable element can be chosen so that thepressurized air (e.g., 0.1 bar gauge to 2 bar gauge) leaks through themembrane in a chosen period of time (e.g., 5% pressure decrease in 8hours). Additionally other fluids (e.g., air, water, oil, glycerin) canbe used as the interior medium. A pumping mechanism can be used topressurize the interior medium. For example a manual pump, electricalpumps, and chemical pumps (e.g., electrolysis). Sealed volume 30 isformed between expandable element 70 and tympanic membrane 40.Expandable element 70 may seal ear canal 50 from sound in ambientenvironment 20 external to ear canal 50.

FIG. 2 is a graph of the occlusion effect as a function of soundisolation in accordance with an exemplary earpiece of the presentinvention. The example illustrates occlusion effect values when anexemplary earpiece is sealed at various sound isolation values. FIG. 2shows that the occlusion effect is reduced as sound isolation isincreased. Conversely, the occlusion effect increases as the soundisolation decreases.

FIG. 6 illustrates sound isolation (attenuation+reflection) results as afunction of inflation plotted in semi-log scale. Note that the inflationcan be varied to obtain a variation in the attenuation and/or acousticreflection. Additionally the inflation medium (interior medium) can beeither a liquid (e.g., water, baby oil, mineral oil), a gas (e.g., H2Ovapor, H2, O2 gas), or a combination of both. Thus in accordance with atleast one exemplary embodiment sound isolation can be increased as thepressure is increased above a particular seal pressure value. However ifthe expandable element is a stressed membrane, then there can be anelongation percentage where the acoustic transmission through themembrane is higher than at larger or lower elongation percentage. Forexample if the stressed membrane is stretched to 50% elongation in onedimension the acoustic transmission can be lower than unstretched or150% elongation stretched (stressed) membranes. The seal pressure valueis the pressure at which the inflatable system (an example of anexpandable element) has conformed to the inside of the orifice (e.g.,whether regular or irregular) such that a drop between the soundpressure level on one side of the inflatable system is different fromthe sound pressure level on the opposite side of the inflatable systemby a drop value in a short period of time. For example when a sudden(e.g., 1 second) drop (e.g., 3 dB) occurs at a particular seal pressurelevel (e.g., 2 bar). For example if a balloon is used where the mediumis air, an internal pressure of 1.2 bar absolute (0.2 bar gauge) canresult in a sound isolation of 20+ dB across the balloon. Forpermeability consideration, for example suppose one wishes inflation tolast for 8 hours with less than 5% internal loss of pressure, thepermeability will have to be much better than silicon, for exampleTeflon. For variable volume balloons (such as silicon balloons) varioushigh elongation materials (some over 1000%) can have the requisitepermeability.

FIG. 7 illustrates an inflatable system 300 comprising an insertionelement (e.g., 320, multi-lumen tube) and an expandable element (e.g.,330, urethane balloon, nylon balloon). The expandable element can befilled with an expanding medium (e.g., gas, liquid, electroactivepolymer or gel) fed via a supply tube (e.g., 340). The deviceillustrated in FIG. 7 illustrates a flange 310 (e.g., made of plastic,foam, rubber) designed to stop at a designated position in the orifice(e.g., at the opening of the orifice), and an instrument package (e.g.,350) can include additional devices and equipment to support expansioncontrol (e.g., power supply and leads, gas and/or fluid generationsystems).

FIG. 8 illustrates at least one exemplary embodiment for pressuregeneration and control, designated generally as system 400. Thenon-limiting example illustrated includes a balloon (e.g., 430), atleast one pressure control valve (e.g., 420A, 420B); electrodes 410, aporous plug (e.g. 440, micro pore plastics that allow gas to pass butblock fluid motion), and optionally a membrane (e.g., 415, Nafion™) thatabsorbs the electrolysis medium (e.g., H2O with NaCl dissolved at 0.001mole/liter) allowing a current to pass between the electrodes as if theelectrodes were essentially in free electrolysis material, and at thesame time preventing the electrodes from touching. The membranefacilitates close placement of the electrodes increasing the electricfield and hence the current. As illustrated the seal pressure value isas discussed above, the operating pressure is some value greater thanthe seal pressure value (e.g., 20% greater) at which an expandableelement operates for a given condition. FIG. 8 illustrates anelectrolysis system where the gas generated passes through a porous pluginto a chamber that has control valves. The control valves are designedto allow a certain gauge pressure value to be reached inside the chamber(e.g., 0.25 bar, 0.5 bar gauge) while allowing gas from the outside ofthe chamber to enter if the gauge pressure value drops below a value(e.g., −0.5 bar gauge), where the gauge pressure in this instance iscalculated as the pressure inside the chamber minus the pressure outsidethe chamber. A non-limiting example of sealing time is 12 seconds for aballoon volume of 1000 mm̂3 using <12 volts and less than 300 milliamps.

An example of electrolysis conversion efficiency is conversion at 75%efficient, roughly 4.0 J/per inflation, or roughly 0.0002823 grams H2Ofor roughly 0.2823 mm̂3 H2O.

FIG. 9 is another exemplary embodiment of a pressure generation andmanagement system 500 in accordance with at least one exemplaryembodiment. In this exemplary embodiment the gas formation is controlledby controlling the size of the electric field (e.g., by relativeplacement of the electrodes (e.g., platinum cylinders)). As the gas isgenerated fluid must be displaced and a partially filled balloon 530 canstart to fill. Near the gas formation region a porous plug 540 can beused to let the gas generated pass and a valve 520 (e.g., duckbill, forexample from VERNAY™ or a MINIVALVE™), or other types of valves, such asflapper valves, umbrella valves, spring and ball valves, and any othervalves that have low leak rates (loss of less than 5% internal pressurein 8-16 hours), can be used to control the amount of pressure generated.Note that the fluid moves 550 by being displaced by controlling wherethe bubble formation 560 occurs (e.g., by placing the electrodes closerat the first desired bubble formation point).

FIG. 10 illustrates another pressure generation and management system600, which includes a manual depression bladder (e.g., 680). Whendepressed 670 the gas and/or fluid in the volume defined by thedepression bladder (e.g., 680) can be encouraged (e.g., by correctlyplaced one-way valves (e.g., 620B, 620C)) to move the evacuated gasand/or fluid along a tube to further inflate or pressurize an expandableelement (e.g., 630 Balloon). Another valve (e.g., 620A) can control thelargest value of the pressure.

FIG. 11 illustrates another non-limiting example of a pressuregeneration and management system 700. System 700 includes electrolysismedium 735 and electrodes 710 for generating a gas via electrolysis. Inthe illustrated system 700 an elastic bladder (e.g., 765) provides abladder force 775 that can aid in forcing any formed gas through theporous plug 740. The gas can be moved along a tube to fill balloon 730with expanding medium 717. Valves 720 can control the pressure ofexpanding medium 717 to balloon 730.

FIG. 12 illustrates yet another exemplary embodiment of a pressuregeneration and management system 800. In the system illustrated as gasis formed (via electrolysis medium 835 and electrodes 810), water isdisplaced expanding the elastic bladder 865 with expansion force 845.The expanding elastic bladder (e.g., compliant urethane) producesbladder force 875, displacing a medium (e.g., 837) in a chamber, wherethe displaced medium can further inflate an expanding element (e.g.,Balloon 830) via expanding medium 817. Similar to system 500 (FIG. 9),system 800 includes porous plug 840 and valve 820B for controllingpassage of the generated gas. System 800 may also include valves 820 forcontrolling the pressure to balloon 830.

FIG. 13 illustrates yet another pressure generation and managementsystem 900 according to at least one exemplary embodiment. System 900,similar to system 800 (FIG. 12), includes electrolysis medium 935,electrodes 910, and elastic bladder 965 which has a bladder force 975.As in FIG. 12 the gas is forced through the porous plug (e.g., 940),however in the configuration illustrated a smaller chamber isconstructed with its own inflation bladder (e.g., 985) and the pressurecontrol system (e.g., valves 920A and 920B) are operatively connected tothe smaller chamber. Inflation bladder 985 produces expanding force 945,which displaces a medium (e.g., 937). Displaced medium 937 can inflateballoon 930, via expanding medium 917.

Although not mentioned to this point, the electrodes can vary in shapeand relative size. For example the electrode producing more gas (e.g.,the electrode associated with H formation in water) can be made large insurface area facilitating a greater formation area. Additionally theelectrodes can be separated by an electrolysis medium absorber (e.g.,Nafion™, 1020). FIGS. 14A through 14C illustrate several non-limitingarrangements of electrodes 1010. Note that the electrode material canvary, for example, the electrode may include a conductive material thatwill not oxidize in the electrolysis medium (e.g., stainless steel,platinum, gold). In FIG. 14C, electrolysis system 1000C includes spacer1020 that allows current to flow between electrodes at a level similarto the current without the spacer but separates the electrodes so thereis no shorting (e.g., Nafion™). This configuration can also keep air inbut not water.

FIG. 15 illustrates at least one pressure generation and managementsystem 1100 in accordance with at least one exemplary embodiment. Inthis system the electrodes 1110 are surrounded by a water soluble(porous) membrane 1191 (e.g., Nafion™), so that when gas is producedwater is forced through the membrane 1191 while gas is still trappedinside the enclosed membrane chamber. An opening connected to a porousplug 1140 can allow the gas trapped to escape, and the pressure can becontrolled by placing valves 1120A, 1120B after the porous plug 1140.Note that the electrodes 1110 can be positioned relative to each otherto control the gas formation 1155 in electrolysis medium 1135. Displacedmedium 1136 may be used to inflate balloon 1130.

Note that several configurations illustrate gas as the expanding and/ordisplaced medium. Note that other exemplary embodiments can use the sameconfiguration for liquids. For example the displaced medium (e.g., 937)in FIG. 13 could be a fluid (gas or liquid).

At least one exemplary embodiment is directed to a device (e.g., anocclusion effect mitigation device, a sound isolation device, anearpiece) comprising: an insertion element (e.g., catheter, catheterwith multiple interior channels, tube, body of an earpiece (thuspossible irregular)); and an expandable element (e.g., stressedmembrane, balloon, electroactive membrane, stressed foam or acombination of these) operatively attached to the insertion element,where the expandable element is configured to expand against a portionof the walls of a channel (e.g., an ear canal, nose, pipe) where thedevice is configured to seal the channel when expanded (e.g., inflated).Upon sealing the device can reduce sound transmission and/or theocclusion effect in any sealed chamber. Note that the catheter can haveat least one interior channel and the interior channel can transmitacoustic energy. In at least one exemplary embodiment the expandableelement is a balloon, with an expanding medium inside the balloon, wherethe expanding medium is at an operating pressure. The balloon can bevariable volume (e.g., made of a material with an linear elongation >50%at operating pressure) or a constant volume balloon (e.g., a balloonmade to a certain shape where upon inflation at an operating pressuredoes not expand more than 100% by volume from its shape volume). Notethat the balloon shape can vary and be irregular or regular, for exampledisk shaped, conical, and/or spherical. Note that the operating pressurecan be between 0.15 and 1 bar gauge pressure. Also note that the fluidcan be ambient air.

Thus, the description of the invention is merely exemplary in natureand, thus, variations that do not depart from the gist of the inventionare intended to be within the scope of the exemplary embodiments of thepresent invention. Such variations are not to be regarded as a departurefrom the spirit and scope of the present invention.

What is claimed is:
 1. A device configured to be inserted in an earcanal, the device comprising: an expandable element including apartially inflated balloon and an expanding medium in the balloon, theexpandable element configured to be expanded to a first operatingpressure such that the expandable element conforms to a surface of theear canal and such that, at the first operating pressure, the expandableelement forms a chamber within the ear canal that is sealed from anoutside environment; and an insertion element operatively attached tothe expandable element, where the first operating pressure of theexpanding medium is increased to a second operating pressure, to controlan amount of sound isolation provided by the expandable element to theear canal, thereby effecting an occlusion effect by the expandableelement.
 2. The device according to claim 1, where the insertion elementis a catheter configured to transfer the expanding medium to theballoon.
 3. The device according to claim 2, where the catheter has atleast one interior channel.
 4. The device according to claim 3 where theat least one interior channel is configured to transmit acoustic energy.5. The device according to claim 2, where the catheter is coupled to apressure generation system, the pressure generation system configured toprovide the expanding medium to the expandable element via the catheter.6. The device according to claim 5, where the pressure generation systemincludes at least one of an electrolysis pump, an electrical pump or amanual pump.
 7. The device according to claim 1, where the balloon is atleast one of disk shaped, conical or spherical.
 8. The device accordingto claim 1, where the balloon is configured to include a linearelongation greater than 50% when inflated at the second operatingpressure.
 9. The device according to claim 8, where the second operatingpressure is between 0.15 and 1 bar gauge pressure.
 10. The deviceaccording to claim 9, where the expanding medium includes air.
 11. Amethod for occluding an ear canal comprising: expanding a partiallyinflated balloon in the ear canal to a first operating pressure via anexpanding medium in the balloon such that the balloon conforms to asurface of the ear canal and such that, at the first operating pressure,the balloon forms a chamber within the ear canal that is sealed from anoutside environment; and increasing the first operating pressure of theexpanding medium to a second operating pressure to control an amount ofsound isolation provided by the balloon to the ear canal, therebyeffecting an occlusion effect by the expandable element.
 12. The methodaccording to claim 11, where the balloon is configured to include alinear elongation greater than 50% when inflated at the second operatingpressure.
 13. The method according to claim 11, where the secondoperating pressure is between 0.15 and 1 bar gauge pressure.